Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serological Profile
研究概览
简要总结
An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis
详细描述
The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2.
Patients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
- •Informed consent obtained and signed
排除标准
- •Refusal to repeat blood sampling if the first one was badly performed
- •Informed consent not obained
结局指标
主要结局
Serological Profile
时间窗: Inclusion
Number of patients with positive serological test of SARS Cov2
次要结局
未报告次要终点
研究者
faida agili
Director of Autoimmune Diseases Research Unit (UR17DN02) and Professor in internal medicine departement. Sponsor and Principal Investigator
Military Hospital of Tunis